Industrial Innovation Protection Law Required Before USMCA

In the upcoming days, the Mexican Congress is expected to define the Industrial Innovation Protection Law as part of the national USMCA agreements, which is expected to come into force in two days, June 1.

According to a recent declaration from the General Director of the Mexican Institute of Industrial Property (IMPI), the updates to the legal framework of this law provide legal certainty, compliance with international commitments, support for Mexican creators, digital transformation and operational efficiency. He also pointed out that “Patents allow their owner to enjoy exclusivity for a given period. However, the day after the patent expires, we must have a generic medicine at a lower cost and with quality.”

By the end of 2019, controversy around patents arose when, during USMCA negotiations, it was said that the clause protecting clinical data of biotech drugs for 10 years would be eliminated. According to a release by AMIIF, this would “inhibit incentives toward research and development of innovative medicines in a scenario in which the available treatments to treat and cure many of the diseases that today affect the Mexican population are no longer sufficient.” During a conference, the subject was later clarified. “USMCA will promote the protection of intellectual property assets and provide the freedom to produce or license products and processes with partners in both the US and Mexico,” said Wilbur Ross, US’ Minister of Commerce. In that same conference, Mexico agreed to implement the Industrial innovation Protection law before USMCA’s enforcement.

This new law would have to be structured considering the current Bolar Clause, which is in charge of allowing generic drug manufacturers to prepare all required studies and paperwork before patents expire so production can start immediately after the patent protection term ends. The clause allows generic laboratories to start research on the drug three years before the patent on chemical drugs expires and eight years on the case of biotechnological patents.

The Senate has already approved the drafts of this new law but, according to AMELAF, it allows so-called second-use patents or secondary patents, which can extend patents for innovative drugs thus delaying the entry of generics. Members of the Senate have been vocal about their opinions regarding the new law, declaring that this would “delay the production of generics, which care for the health and economy of Mexicans.” The Senate also seeks to eliminate the clauses referring to the eight and three-years restrictions for generic laboratories so they can start research sooner.

When asking Alejandro Luna of OLIVARES how could Mexico improve the enforcement of IP law regarding pharmaceutical products, he told MBN that a specific improvement for the pharmaceutical sector is expected through the establishment of a system of compensation due to delays in the granting of patents by IMPI. “It is important to mention that the time frame for granting patents in Mexico is not a real problem. However, the establishment of this compensation mechanism would assure good practices from IMPI in the granting of patents and could be helpful in the exceptional cases when IMPI may delay patents.”